Regulatory aspects for Biologic product licensing in India

  • Sanjeev Kumar Maurya Amity University, India
  • Vikesh Shukla
  • Prachi Kaushik
  • SP Yamini Kanti
  • Anshul Bansal


Biologics are the medicinal/ therapeutic/ diagnostic/ preventive preparations composed or derived from living organisms and their spin-off for human use. They include serums, vaccines, antitoxins, blood, antigens and blood components, gene therapy, tissues etc. Biotechnology is used as a unique approach in manufacturing such medicinal agents. The Indian National regulatory authority (CDSCO) is the body that is responsible for manufacturing and import of biological products in India. Biotechnology provides innovative solutions to medical field with more than 200 biologic medicines and vaccines. These developments benefits millions of patients worldwide and more than 600 products under development. At present these products can also be produced by manufacturers other than the innovator, with the expiry of some of patents. These new biotechnological medicines commonly referred to as ‘similar biologics’ offer a major opportunity to provide greater access to reasonable healthcare for several lifesaving medicines. India has emerged as one of the leading providers to the world market for ‘Biosimilars’. These may be considered to be very essential economical and therapeutical element for the pharmaceutical market in India. The Indian National Regulatory Authority is considered to be responsible for evaluating safety, efficacy and quality of all pharmaceuticals in India. The Department of Biotechnology in India is the department that governs the development, pre-clinical studies of all Biologicals.

Keywords: Biologicals, CDSCO, RCGM, DBT, DCGI


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How to Cite
Maurya, S. K., V. Shukla, P. Kaushik, S. Y. Kanti, and A. Bansal. “Regulatory Aspects for Biologic Product Licensing in India”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 1, Mar. 2019, pp. 1-5, doi:10.22270/ijdra.v7i1.287.